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Trial Title:
In Vivo Confocal Microscopy Tumor Atlas Study
NCT ID:
NCT01012154
Condition:
Brain Neoplasms
Conditions: Official terms:
Brain Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Endomicroscope
Description:
Endomicroscopic images and biopsies are taken at several positions on the tumor.
Arm group label:
All patients
Summary:
This study aims to create an atlas based on the preliminary experience of the first
feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used
during neurosurgery to provide in vivo histology that enables documentation of
neurological pathology across a range of tumor ypes and grades, suitable for comparison
with traditional histopathology from site-matched biopsies.
Detailed description:
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to
be performed on living tissue in vivo. The procedure involves a small endoscope which is
placed gently into contact with the tissue, providing significant in vivo magnification
on a scale similar to that obtained by the pathology laboratory microscope. It is already
in clinical use in the field of gastroenterological endoscopy, and investigational use in
laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy
has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and
neurosurgery.The study will use both endomicroscopy and biopsy to document the
histological appearance of a range of neurological tumour types and grades.
In subsequent analysis, the confocal image data and corresponding histology data and
images will be used to document reliably observable features in the confocal images that
are relevant to histopathology interpretation. Relevant images will be selected and
discussed by comparison to frozen or permanent section histology for compilation into an
atlas documenting comparison for the tumors seen in the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- All patients with neurological pathology requiring surgery in which tumour resection
might be evaluated by using biopsy
Exclusion Criteria:
- History of allergy to fluorescein
- Patients on beta-blockers or ACE inhibitors
- Pregnant women
- Inability to give informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Address:
City:
Phoenix
Zip:
85013
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Peter Nakaji, MD
Email:
Principal Investigator
Investigator:
Last name:
Robert F Spetzler, MD
Email:
Sub-Investigator
Investigator:
Last name:
Kris Smith, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jennifer Eschbacher, MD
Email:
Sub-Investigator
Start date:
November 2009
Completion date:
December 2010
Lead sponsor:
Agency:
Carl Zeiss Surgical GmbH
Agency class:
Industry
Source:
Carl Zeiss Surgical GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01012154
